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Patient Positioners

by Span-America Medical Systems, Inc. 4 variants

Ref 50638-511Model Patient Positioners

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++H933POSITIONERSER Basic UDI-DI H93350638511UDI-DIDate11 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID NumberH93350638511 UDI-DI Date6 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Span-America
Generic Name
Freestanding patient positioner, single-use
Device Name
Patient Positioners
Model / Ref / Catalog
Patient Positioners, 50638-511, Span Aids
Primary DI / UDI-DI
H93350638511
Basic UDI-DI
++H933POSITIONERSER
FDA Product Code
KIC
EMDN Code
V0811 Heel, elbow and knee anti-decubitus protection aids
GMDN Term
Freestanding patient positioner, single-use
Device Class
Class I
Regulation Number
890.3175
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Patient Positioners
50638-511
GUDID
Span Aids

Manufacturer details

EUDAMED SRN
US-MF-000002745
Authorised representative
Advena SRL IT-AR-000051131

Other devices from Span-America Medical Systems, Inc.

See all devices from Span-America Medical Systems, Inc. →

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No